Corneal Endothelial Cell LossNCT02276638
Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality
An observational study of Corneal Endothelial Cell Loss, run by Nidek Co. LTD. at 1 site in United States.
Trial summary
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The secondary objective is to evaluate any adverse events found during the clinical study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Endothelial Cell Loss
- What is being tested?
- Specular Microscope Nidek CEM-530 and Specular Microscope Konan CELLCHEK XL
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ophthalmology Practice
Who may be able to join
- Non-Pathologic: Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site,and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study.
- Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions:
- History of post-op surgical trauma including bullous keratopathy
- History of corneal transplant
- Physical injury or trauma to the cornea
- Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
- Keratoconus
- Long term PMMA contact lens use (greater than 3 years)
Who cannot join
- Non-Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions:
- History of post-op surgical trauma including bullous keratopathy
- History of corneal transplant
- Physical injury or trauma to the cornea
- Long term Fuch's dystrophy, Guttata or other corneal endothelial dystrophies
- Keratoconus
- Long term PMMA contact lens use (greater than 3 years)
- Pathologic: History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device. Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) CEM-530 and KONAN CELLCHEK PLUS images in either eye.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: Comparative Study of the Specular Microscopes for Center Point Method and Corner Point Method for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area and % Hexagonality.
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The secondary objective is to evaluate any adverse events found during the clinical study.
Read the detailed description
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method.
- Conditions
- Corneal Endothelial Cell Loss
- Being tested
- Specular Microscope Nidek CEM-530, Specular Microscope Konan CELLCHEK XL
- Medical subject headings
- Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specular Microscope Nidek CEM-530Device
Nidek CEM-530
Specular Microscope Konan CELLCHEK XLDevice
Konan CELLCHEK XL
| Study group | Role | What they receive |
|---|---|---|
| 18-28 years old Non-pathologic | Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL Receives: Device: Specular Microscope Nidek CEM-530; Device: Specular Microscope Konan CELLCHEK XL | |
| 29-80 years old Non-pathologic | Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL Receives: Device: Specular Microscope Nidek CEM-530; Device: Specular Microscope Konan CELLCHEK XL | |
| 29-80 years old pathological | Device: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL Receives: Device: Specular Microscope Nidek CEM-530; Device: Specular Microscope Konan CELLCHEK XL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center Method Corneal Endothelial Cell Density
Measured: single time point - 1 day
Center Method Coefficient of Variation of Endothelial Cell Area
Coefficient of variation(CV) is that Standard deviation (SD) divided by the average area of endothelial cell analyzed
Measured: single time point - 1 day
Percentage Hexagonality
Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium
Measured: single time point - 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal Endothelial Cell LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nidek Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, Andover Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276638
- Sponsor's protocol ID
- CEM-530-US-0002
- Status last verified
- Mar 2019
- First submitted
- 14 Oct 2014
- Last updated
- 20 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Specular Microscopes for Center Point Method and Corner Point Method for the Measurements of Endothelial Cell Density Measurements, Coefficient of Variation of Endothelial Cell Area and % Hexagonality.
- ClinicalTrials.gov ID
- NCT02276638
- Acronym / sponsor ID
- CEM-530-US-0002
- Conditions
- Corneal Endothelial Cell Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Nidek Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Posted 11 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The secondary objective is to evaluate any adverse events found during the clinical study.
Detailed description
The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek CEM-530 Center point method and Corner point method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 18-28 years old Non-pathologic | – | Device: Specular Microscope Nidek CEM-530, Device: Specular Microscope Konan CELLCHEK XLDevice: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL |
| 29-80 years old Non-pathologic | – | Device: Specular Microscope Nidek CEM-530, Device: Specular Microscope Konan CELLCHEK XLDevice: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL |
| 29-80 years old pathological | – | Device: Specular Microscope Nidek CEM-530, Device: Specular Microscope Konan CELLCHEK XLDevice: Specular Microscope Nidek CEM-530 Device: Specular Microscope Konan CELLCHEK XL |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ophthalmology Practice
Key inclusion criteria (8 listed)
- Non-Pathologic: Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site,and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study.
- Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions:
Key exclusion criteria (8 listed)
- Non-Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date. Subjects who agree to participate in the study. At least one eye with any of the following conditions:
- Pathologic: History of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device. Fixation problems which may prevent obtaining at least poor quality (refer to Figure 1) CEM-530 and KONAN CELLCHEK PLUS images in either eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specular Microscope Nidek CEM-530Nidek CEM-530 | Device | 18-28 years old Non-pathologic, 29-80 years old Non-pathologic, 29-80 years old pathological |
| Specular Microscope Konan CELLCHEK XLKonan CELLCHEK XL | Device | 18-28 years old Non-pathologic, 29-80 years old Non-pathologic, 29-80 years old pathological |
Primary outcome
Center Method Corneal Endothelial Cell Density
Time frame: single time point - 1 day
Center Method Coefficient of Variation of Endothelial Cell Area
Time frame: single time point - 1 day
Coefficient of variation(CV) is that Standard deviation (SD) divided by the average area of endothelial cell analyzed
Percentage Hexagonality
Time frame: single time point - 1 day
Percentage hexagonality(%HEX) is that Proportion of hexagonal cells found in the analyzed endothelium
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Torkildsen, MD principal investigator
Andover Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Endothelial Cell Loss, run by Nidek Co. LTD. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center Method Corneal Endothelial Cell Density (time frame: single time point - 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.